title: Efficacy and safety of traditional chinese medicine (Shenqi particle) for patients with idiopathic membranous nephropathy: a multicenter randomized controlled clinical trial.
abstract: BACKGROUND
  To compare the safety and efficacy of the traditional Chinese medicine Shenqi particle and standard therapy with prednisone and cyclophosphamide (control) in adult patients with idiopathic membranous nephropathy (IMN).
  
  
  METHODS
  Open-label, multicenter, parallel, randomized, controlled clinical trial.
  
  
  METHODS
  From April 2008 to February 2011, a total of 190 patients with biopsy-proven IMN from 7 hospitals in China participated in the study. All patients had nephrotic syndrome with estimated glomerular filtration rate (eGFR) >30 mL/min/1.73 m(2).
  
  
  METHODS
  Shenqi particle (9.6 g 3 times per day) or prednisone (1 mg/kg/d tapering to 0.17 mg/kg/d) and cyclophosphamide (total dose of 9-12 g per square meter of body surface area) for 48 weeks.
  
  
  RESULTS
  Primary outcomes included complete remission, defined as proteinuria (24-hour urine protein excretion) ≤0.3 g/d, or partial remission, defined as proteinuria with protein excretion >0.3-<3.5 g/d and a 50% reduction from its peak value at 48 weeks. Secondary outcomes included serum albumin level, eGFR, doubling of serum creatinine level, end-stage renal disease, and death.
  
  
  RESULTS
  Baseline values for proteinuria and eGFR were 5.34 ± 2.74 g/d and 84.0 ± 27.4 mL/min/1.73 m(2) for the Shenqi particle group and 5.33 ± 2.47 g/d and 83.8 ± 24.9 mL/min/1.73 m(2) for the control group, respectively. 132 patients (63 Shenqi particle group, 69 control group) completed the study. Change in urinary protein excretion in the Shenqi particle group was -3.01 (95% CI, -3.68 to -2.34) g/d, and in the control group, -3.28 (95% CI, -3.98 to -2.58) g/d; the mean difference between groups was 0.27 (95% CI, -0.70 to 1.23) g/d (P = 0.6). Changes in eGFR were 12.3 (95% CI, 4.99 to 19.6) mL/min/1.73 m(2) in the Shenqi particle group and -2.8 (95% CI, -10.32 to 4.77) mL/min/1.73 m(2) in the control group; the mean difference between groups was 15.1 (95% CI, 4.56 to 25.55) mL/min/1.73 m(2) (P = 0.005). Severe adverse events occurred in only the control group (14.5%) and included lung infection, liver injury, and pneumonia.
  
  
  CONCLUSIONS
  High rate of loss to follow-up and lack of observation period prior to the study.
  
  
  CONCLUSIONS
  Shenqi particle may be a promising alternative therapy for adults with IMN and nephrotic syndrome.
authors.affiliation: Department of Nephrology, Longhua Hospital Affiliated to the Shanghai University of Traditional Chinese Medicine, Shanghai, China. Electronic address: yipingchen01@126.com.
authors.forename: Yiping
authors.initials: Y
authors.lastname: Chen
authors.forename: Yueyi
authors.initials: Y
authors.lastname: Deng
authors.forename: Zhaohui
authors.initials: Z
authors.lastname: Ni
authors.forename: Nan
authors.initials: N
authors.lastname: Chen
authors.forename: Xiangmei
authors.initials: X
authors.lastname: Chen
authors.forename: Wei
authors.initials: W
authors.lastname: Shi
authors.forename: Yongli
authors.initials: Y
authors.lastname: Zhan
authors.forename: Fahuan
authors.initials: F
authors.lastname: Yuan
authors.forename: Wei
authors.initials: W
authors.lastname: Deng
authors.forename: Yifei
authors.initials: Y
authors.lastname: Zhong
mesh_terms: D000328:Adult; D000368:Aged; D000893:Anti-Inflammatory Agents / Q000627:therapeutic use; D001706:Biopsy; D002681:China; D003520:Cyclophosphamide / Q000627:therapeutic use; D004365:Drugs, Chinese Herbal / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D005919:Glomerular Filtration Rate / Q000187:drug effects; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use; D007668:Kidney / Q000473:pathology; D007677:Kidney Function Tests; D008297:Male; D008516:Medicine, Chinese Traditional; D008875:Middle Aged; D009404:Nephrotic Syndrome / Q000188:drug therapy / Q000473:pathology; D008517:Phytotherapy; D010936:Plant Extracts / Q000009:adverse effects / Q000627:therapeutic use*; D011241:Prednisone / Q000627:therapeutic use
chemical_list: D000893:Anti-Inflammatory Agents; D004365:Drugs, Chinese Herbal; D007166:Immunosuppressive Agents; D010936:Plant Extracts; C585913:shenqi; D003520:Cyclophosphamide; D011241:Prednisone
keywords: Idiopathic membranous nephropathy; Shenqi particle; clinical trial; cyclophosphamide; prednisone; traditional Chinese medicine